Prospective Cohort Study Evaluating 18FDG PET-CT for the Early Prediction of the Efficacy of Immunotherapy Associated or Not With Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Broncho-Pulmonary Carcinoma

NCT06833229 | Recruiting

• 2 other identifiers: 2021/112021-A00352-39
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this prospective observational pilot study of diagnostic diagnostic performance is that, for patients with NSCLC treated with immunotherapy associated or not with chemotherapy, certain metabolic biomarkers on 18FDG PET scans allow early identification of treatment response (or lack of response to treatment) and optimize prediction of tumor response compared with current standards.

Conditions

Carcinoma, Non-Small-Cell Lung (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Metabolic criteria for PET imaging that can distinguish true tumor progression from pseudo-progression of inflammatory origin (leukocyte infiltrate)

  Calculation of the area of the ROC curve and determination of the optimal threshold of different metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)) and parametric PET image (metabolic glucose rate (Ki), volume of distribution (VD)) to distinguish lesions between true progression from inflammatory pseudoprogressions.

  36 months

Secondary Outcomes (4)

• Incidence of pseudo-progressions versus true tumor progressions at the first PET scan at 6 weeks.

  6 weeks

• Prognostic value of metabolic response PET-CT at 6 weeks and 12 weeks on overall survival at 12, 24 and 36 months

  36 months

• Use of supervised deep-learning algorithms (neural networks) to classify patients as immunotherapy responders or non-responders.

  6 months

• Evaluation of overall survival of patients with oligometastatic progression with maintenance of immunotherapy and targeted irradiation of progressing lesions.

  36 months

Interventions

FDG-PET PROCEDURE

PET scan are performed within 28 days before the start of immunotherapy, then at week 6 and week 12 of follow-up. Various metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)), parametric (metabolic glucose rate (Ki), volume of distribution (VD)) and tumor response based on PERCIST criteria (adapted to immunotherapy) are assessed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with locally advanced or metastatic NSCLC with an indication for immunotherapy combined with concomitant chemotherapy as standard treatment and managed at the Centre Antoine Lacassagne will be eligible.

You may qualify if:

• Age greater than or equal to 18 years,
• Patients with histologically proven, metastatic or locally advanced NSCLC, with indication for immunotherapy (Nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab), in combination or not with chemotherapy molecules (carboplatin, cisplatin, pemetrexed, paclitaxel or nab-paclitaxel), validated by a Multidisciplinary Team and prescribed within the scope of their Marketed Authorization, whatever the line of treatment treatment line,
• ECOG 0 to 3,
• The patient's understanding of the protocol and the note of non-opposition, with oral agreement,
• Patient has not objected to the use of his or her data for medical research. research,
• Patient has social security coverage.

You may not qualify if:

• Age under 18,
• Contraindication to 18FDG PET-CT examinations: severe claustrophobia, unbalanced diabetes at the time of the first PET-CT scan (fasting capillary glucose ≥ 11 mmol),
• Any participation in other biomedical studies involving the drug, medical devices or medical devices or imaging techniques is prohibited, with the exception of biomedical studies,
• Refusal to participate in the present study,
• Contraindication (e.g. hypersensitivity to the active substance or to one of the excipients of immunotherapy or chemotherapy treatments...).
• Vulnerable persons are defined in article L1121-5 to -8:
• Pregnant women, parturients and nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of the provisions of article L. 1121-8,
• and persons admitted to a health or social establishment for purposes other than research purposes,
• adults who are the subject of a legal protection measure, or who are unable to exercise their non opposition

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Study Coordinator

CONTACT

04 92 03 14 76; DRCI-Promotion@nice.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: January 27, 2022
• Primary Completion (Estimated): May 27, 2028
• Study Completion (Estimated): January 27, 2031
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

FR (1)